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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MDT PUERTO RICO OPERATIONS CO SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

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MDT PUERTO RICO OPERATIONS CO SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE Back to Search Results
Model Number 8637-20
Device Problem Premature Elective Replacement Indicator (1483)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/04/2017
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a healthcare provider on 2017-jul-17. It was stated that the pump that was replaced on (b)(6) 2017 had to do with an acute eri issue. It was stated that there were no issues at the time of the new pump placement.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a healthcare provider regarding a patient who was receiving an unknown drug via an implantable infusion pump for an unknown indication for use. It was reported the patient had a magnetic resonance imaging session (mri) done on (b)(6) 2017. The pump was checked after the mri and a motor stall and motor stall recovery occurred. It was reported an elective replacement indicator (eri) occurred message was noted. The message also stated to replace the pump by (b)(6) 2017. At the patient's last refill the eri was 2 years. It was reported that the pump was infusing and no therapy or clinical issue were reported. No symptoms were reported. No further complications were anticipated/reported.
 
Event Description
Additional information was received from a healthcare provider (hcp). The patient was scheduled for a pump removal and replacement in two weeks. Possible acute battery issues and withdrawal identification and treatment were discussed. The premature eri had not been resolved.
 
Manufacturer Narrative
Analysis results were not available at the time of this report. A follow-up report will be sent when analysis is completed. A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from the manufacturing representative on may 22, 2017. The pump was replaced on (b)(6) 2017. It was indicated the therapy was listed as "pain," and the patient was not in a clinical study. The pump was returned to the manufacturer for analysis on may 26, 2017.
 
Manufacturer Narrative
During analysis of the pump, a low battery reset occurred due to an undetermined root cause that resulted in a lab failure. Interrogation of the pump determined it was used to infuse hydromorphone [ 27. 7 mg/ml] at 5. 500 mg/day, clonidine [1,388. 0 mcg/ml] at 275. 6 mcg/day, bupivacaine [33. 3 mg/ml] at 6. 612 mg/day, and sufentanil [155. 4 mcg/ml] at 30. 86 mcg/day. Result code (b)(4) and conclusion code (b)(4) no longer apply. Recent fda coding changes offer limited options for medical device evaluation conclusion coding. Medtronic selected conclusion code (b)(4) because, although the device meets design specification, medtronic made enhancements to the design making this the closest code available with respect to this event. If information is provided in the future, a supplemental report will be issued.
 
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Brand NameSYNCHROMED II
Type of DevicePUMP, INFUSION, IMPLANTED, PROGRAMMABLE
Manufacturer (Section D)
MDT PUERTO RICO OPERATIONS CO
rd 31 km 24 hm 4
juncos PR 00777
Manufacturer (Section G)
MDT PUERTO RICO OPERATIONS CO
rd 31 km 24 hm 4
juncos PR 00777
Manufacturer Contact
lisa woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key6545577
MDR Text Key100950009
Report Number3004209178-2017-09681
Device Sequence Number1
Product Code LKK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P860004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 07/19/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/04/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/14/2012
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/26/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/17/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/15/2011
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-3043-2011

Patient Treatment Data
Date Received: 05/04/2017 Patient Sequence Number: 1
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